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Diabetes Mellitus, Type 1INRANGENCT04414280

The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs

An observational study of Diabetes Mellitus, Type 1, run by Universitaire Ziekenhuizen KU Leuven at 38 sites in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Since February 2019 the first hybrid closed-loop insulin pump, the Medtronic MiniMed 670G system, has been offered to people with type 1 diabetes in Belgium. Despite previous studies, the impact of these automated insulin delivery systems on glycemic management and patient-reported outcomes (PROMs) under real-world… Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Medtronic MiniMed 670G, Medtronic MiniMed 780G and Omnipod 5
Type of treatment
Medical device
How many people
1,600 participants
Where
38 sitesBelgium
Study dates
12 Mar 2020to Apr 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants will be recruited at 26 diabetes convention hospitals in Belgium

People with type 1 diabetes, aged 7 years and older who start with the Medtronic MiniMed 670G or 780G system, aged 6 years and older who start with the Tandem t:slim X2 Control-IQ or those aged 2 years and older who start with the Omnipod 5 in the participating centers and who signed informed consent or gave informed assent (pediatrics) are eligible to participate. For the safety study, children with type 1 diabetes aged 2-6 years old who start(ed) with the Medtronic MiniMed 780G system in Manual Mode, whose parents agree to enable Auto Mode (after at least 4 weeks of Manual Mode) and whose parents signed informed consent can be included. Auto Mode enablement is only possible if time since type 1 diabetes diagnosis is at least 6 months.

The decision about which person with type 1 diabetes to start, is left to the clinical judgement of the treating health care professional.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

Belgium38 sites

  • AZORG

    Aalst, 9300

  • GZA Ziekenhuizen - campus Sint-Vincentius

    Antwerp, 2018

  • ZAS - pediatrics

    Antwerp, 2020

  • Hôpital d'Arlon

    Arlon, 6700

  • Imeldaziekenhuis

    Bonheiden, 2820

  • AZ Sint-Jan - pediatrics

    Bruges, 8000

  • AZ Sint-Jan

    Bruges, 8000

  • Hôpital Universitaire des Enfants Reine Fabiola - pediatrics

    Brussels, 1020

  • Hôpital Erasme

    Brussels, 1070

  • Cliniques Universitaires St. Luc - pediatrics

    Brussels, 1200

  • Cliniques Universitaires St. Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi - pediatrics

    Charleroi, 6000

  • UZ Antwerpen - pediatrics

    Edegem, 2650

  • UZ Antwerpen

    Edegem, 2650

  • ZOL Sint-Jan

    Genk, 3600

  • UZ Gent - pediatrics

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • Jessa - pediatrics

    Hasselt, 3500

  • Jessa

    Hasselt, 3500

  • UZ Brussel - pediatrics

    Jette, 1090

  • UZ Brussel

    Jette, 1090

  • AZ Groeninge - campus kennedylaan

    Kortrijk, 8500

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

  • CHR Citadelle

    Liège, 4000

  • CHU de Liège - site du Sart Tilman

    Liège, 4000

  • Clinique CHC Montlégia - pediatrics

    Liège, 4000

  • Clinique CHC Montlégia

    Liège, 4000

  • CHR Citadelle - pediatrics

    Liège, 4030

  • ZOL Maas en Kempen - pediatrics

    Maaseik, 3680

  • CHU Helora

    Mons, 7000

  • AZ Oostende

    Ostend, 8400

  • AZ Delta - pediatrics

    Roeselare, 8800

  • AZ Delta

    Roeselare, 8800

  • Vitaz - pediatrics

    Sint-Niklaas, 9100

  • VITAZ

    Sint-Niklaas, 9100

  • AZ Turnhout - pediatrics

    Turnhout, 2300

  • GZA Ziekenhuizen - campus Sint-Augustinus

    Wilrijk, 2610

  • CHU UCL Namur - pediatrics

    Yvoir, 5530

Other trials in Belgium

About this study

Official title: The Impact of Hybrid Closed-loop Insulin Delivery (Medtronic MiniMed 670G and 780G System, Tandem t:Slim X2 Control-IQ, and Omnipod 5) on Glycemic Control and Patient-reported Outcomes in People Living With Type 1 Diabetes: a Multicenter Real-world Observational Study and Safety Study in Young Children (2-6 Years Old) in Belgium

Since February 2019 the first hybrid closed-loop insulin pump, the Medtronic MiniMed 670G system, has been offered to people with type 1 diabetes in Belgium. Despite previous studies, the impact of these automated insulin delivery systems on glycemic management and patient-reported outcomes (PROMs) under real-world conditions is still unclear. Therefore, this prospective, multicenter real-world observational study will evaluate the real-world impact of the Medtronic MiniMed 670G, Medtronic MiniMed 780G, Tandem Control-IQ and Omnipod 5 systems, separately, on glycemic management and PROMs in people living with type 1 diabetes and to evaluate the safety of the Medtronic MiniMed 780G in young children with type 1 diabetes (2-6 years old). Participants will be followed in routine clinical practice for a period of 24 months after initiation of the system. The primary endpoint is the evolution of time spent in range (defined as a sensor glucose value between 70 and 180 mg/dL) from before start to 12 months after start of hybrid closed-loop therapy.

Since not much is known about the impact of hybrid closed-loop on partners of adults living with type 1 diabetes, an optional substudy (INRANGE-PARTNER) will be performed investigating the quality of life in partners of adults of type 1 diabetes using hybrid closed-loop therapy. More specifically, the substudy will compare the quality of life of partners of type 1 diabetes patients both before and after implementation of hybrid closed-loop therapy.

Being tested
Medtronic MiniMed 670G, Medtronic MiniMed 780G, Tandem Control-IQ, Omnipod 5
Keywords
hybrid closed-loop therapy, real-world, automated insulin delivery
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic MiniMed 670GDevice

    The Medtronic Minimed 670G system is a form of hybrid closed-loop insulin delivery. The Medtronic MiniMed 670G system automatically adjusts basal insulin every five minutes based on CGM readings to reach a glucose target of 120 mg/dL, the SmartGuard Auto Mode. Patients still need to enter their carbohydrate intake and administer meal-time and correction boluses. Before Auto Mode is introduced, the Medtronic MiniMed 670G system has to be worn in Manual Mode. In contrast to Auto Mode, Manual Mode features an insulin stop up to 30 minutes before or when reaching preset low limits (suspend before/on low) and an automatic insulin restart when blood sugar levels recover. During Manual Mode the pump 'becomes familiar with' the daily insulin need of the patient. This information will be used when in Auto Mode.

  • Medtronic MiniMed 780GDevice

    The Medtronic Minimed 780G system differs in several aspects from the MiniMed 670G system. In Auto Mode, the user can choose from two target levels for even more stricter glucose control (100 mg/dL and 120 mg/dL) and correction boluses are now automated without the need of user interaction. When administering meal boluses, no capillary blood glucose value is required. The safety feature to exit from Auto Mode to Manual Mode was too strict in the Minimed 670G. In the Minimed 780G this is more flexible to overcome this frequently reported patient frustration.

  • Tandem Control-IQDevice

    The Tandem t:slim X2 Control-IQ consists of the Tandem t:slim X2 insulin pump with Control-IQ technology, and integrates with the Dexcom G6 CGM-device via Bluetooth. Blood glucose readings for calibration are not required. The Tandem t:slim X2 Control-IQ automatically adjusts basal insulin based on CGM readings to reach a glucose target range between of 112-160 mg/dL. Patients still need to enter their carbohydrate intake and administer meal-time boluses, but the system automatically increases the basal insulin dose or gives automated correction boluses in case of high blood glucose levels. The technology offers optional settings for sleep and exercise, with different glucose targets in order to match the insulin need during these activities. New versions of the pump software can be downloaded and installed remotely via the user's own computer.

  • Omnipod 5Device

    The Omnipod® 5 (Insulet Corporation, Acton, MA, USA) consists of the tubeless Omnipod 5 insulin pump system with SmartAdjust™ technology and integrates with the Dexcom G6 and Freestyle Libre 2 plus CGM-device via Bluetooth. The Omnipod 5 system automatically adjusts insulin delivery every 5 minutes based on CGM readings to reach a customizable glucose target between 110-150 mg/dL. People still need to enter their carbohydrate intake and administer meal-time boluses, but the system automatically adjusts insulin delivery in response to predicted glucose levels. The technology offers an Activity feature with a higher glucose target to reduce the risk of hypoglycemia during exercise or other periods of increased insulin sensitivity. As a tubeless patch pump system, insulin delivery is managed directly through the wearable Pod, which is controlled via the dedicated controller or compatible smartphone application.

Study groups in NCT04414280
Study groupRoleWhat they receive
People with type 1 diabetes using Medtronic MiniMed 670GPeople with type 1 diabetes, aged 8 years or older, who start with the Medtronic MiniMed 670G system (as part of routine clinical practice) in one of the 26 participating centers and who signed informed consent are eligible to participate. The decision about which person to start, is left to the clinical judgement of the treating health care professional.
Receives: Device: Medtronic MiniMed 670G
People with type 1 diabetes using Medtronic MiniMed 780GPeople with type 1 diabetes, aged 7 years or older, who start with the Medtronic MiniMed 780G system (as part of routine clinical practice) in one of the 26 participating centers and who signed informed consent are eligible to participate. The decision about which person to start, is left to the clinical judgement of the treating health care professional.
Receives: Device: Medtronic MiniMed 780G
People with type 1 diabetes using Tandem Control-IQPeople with type 1 diabetes, aged 6 years or older, who start with the Tandem Control-IQ system (as part of routine clinical practice) in one of the 26 participating centers and who signed informed consent are eligible to participate. The decision about which person to start, is left to the clinical judgement of the treating health care professional.
Receives: Device: Tandem Control-IQ
Young children (2-6 years) with type 1 diabetes using Medtronic MiniMed 780GYoung children with type 1 diabetes, aged 2-6 years, who start with the Medtronic 780G system (as part of routine clinical practice) in one of the 26 participating centers and whose parents signed informed consent are eligible to participate. The decision about which child to start, is left to the clinical judgement of the treating health care professional.
Receives: Device: Medtronic MiniMed 780G
People with type 1 diabetes using Omnipod 5People with type 1 diabetes, aged 2 years or older, who start with the Omnipod 5 system (as part of routine clinical practice) in one of the 26 participating centers and who signed informed consent are eligible to participate. The decision about which person to start, is left to the clinical judgement of the treating health care professional.
Receives: Device: Omnipod 5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in range

    The evolution of percentage of time spent in range (sensor glucose 70-180 mg/dL) from before start to 12 months after start

    Measured: 12 months

Secondary outcomes (28)

  1. Time in range

    Percentage of time spent in range (sensor glucose 70-180 mg/dL), with exclusion of the primary endpoint

    Measured: from before start to 4, 8, 12 and 24 months after start

  2. Time in tight range

    Percentage of time spent in tight range (sensor glucose 70-140 mg/dL)

    Measured: from before start to 4, 8, 12 and 24 months after start

  3. Time in level 2 hypoglycemia

    Percentage of time spent in level 2 hypoglycemia (sensor glucose <54 mg/dL)

    Measured: from before start to 4, 8, 12 and 24 months after start

  4. Time in level 1 hypoglycemia

    Percentage of time spent in level 1 hypoglycemia (sensor glucose <70 mg/dL and ≥54 mg/dL)

    Measured: from before start to 4, 8, 12 and 24 months after start

  5. Time below range

    Percentage of time spent below range (sensor glucose <70 mg/dL)

    Measured: from before start to 4, 8, 12 and 24 months after start

  6. Time above range

    Percentage of time spent above range (sensor glucose >180 mg/dL)

    Measured: from before start to 4, 8, 12 and 24 months after start

  7. Time in level 1 hyperglycemia

    Percentage of time spent in level 1 hyperglycemia (sensor glucose ≥180 mg/dL and <250 mg/dL)

    Measured: from before start to 4, 8, 12 and 24 months after start

  8. Time in level 2 hyperglycemia

    Percentage of time spent in level 2 hyperglycemia (sensor glucose >250 mg/dL)

    Measured: from before start to 4, 8, 12 and 24 months after start

  9. Time above 140 mg/dL

    Percentage of time spent >140 mg/dL

    Measured: from before start to 4, 8, 12 and 24 months after start

  10. HbA1c

    HbA1c

    Measured: from before start to 4, 8, 12 and 24 months after start

  11. Mean glucose concentration

    Mean glucose concentration

    Measured: from before start to 4, 8, 12 and 24 months after start

  12. Glycemic variability

    Glycemic variability: coefficient of variation (CV), standard deviation (SD) and mean amplitude of glycemic excursions (MAGE)

    Measured: from before start to 4, 8, 12 and 24 months after start

  13. Glucose management indicator

    Glucose management indicator

    Measured: from before start to 4, 8, 12 and 24 months after start

  14. Glycemic risk index

    Glycemic risk index

    Measured: from before start to 4, 8, 12 and 24 months after start

  15. Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))

    Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))

    Measured: from before start to 4, 8, 12 and 24 months after start for adults

  16. Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (<4 times "R"))

    Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (<4 times "R"))

    Measured: from before start to 4, 8, 12 and 24 months after start for adults and children

  17. Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))

    Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))

    Measured: from before start to 4, 8, 12 and 24 months after start for adults and children

  18. Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))

    Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))

    Measured: from before start to 4, 8, 12 and 24 months after start for adults

  19. Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))

    Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))

    Measured: from before start to 4, 8, 12 and 24 months after start for adults

  20. Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))

    Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))

    Measured: from before start to 4, 8, 12 and 24 months after start for adults

  21. Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))

    Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))

    Measured: from before start to 4, 8, 12 and 24 months after start for adults

  22. Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))

    Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))

    Measured: from before start to 4, 8, 12 and 24 months after start for adults

  23. Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G/780G system (multiple choice)

    Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G/780G system (multiple choice)

    Measured: at 4, 8, 12 and 24 months after start of the Medtronic MiniMed 670G and 780G system for adults and children

  24. Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, worry (scale: 0 (not worried) - 60 (very worried))

    Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, worry (scale: 0 (not worried) - 60 (very worried))

    Measured: from before start to 4, 8, 12 and 24 months after start for children

  25. Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))

    Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))

    Measured: from before start to 4, 8, 12 and 24 months after start for children

  26. The Diabetes Quality of Life for Youth (DQOLY) questionnaire

    The Diabetes Quality of Life for Youth (DQOLY) questionnaire

    Measured: from before start to 4, 8, 12 and 24 months after start for children

  27. Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)

    Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)

    Measured: from before start to 4, 8, 12 and 24 months after start for parents

  28. The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents

    The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents

    Measured: from before start to 4, 8, 12 and 24 months after start for parents

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start12 Mar 2020
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04414280
Sponsor's protocol ID
S63351
Acronym
INRANGE
Status last verified
May 2026
First submitted
10 Apr 2020
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • De Meulemeester J, Valgaerts L, Tenoutasse S, Gies I, den Brinker M, Fudvoye J, Mouraux T, Louis J, Lambert S, Van Loocke M, Smeets G, Lemay A, Ryckx S, Depoorter S, Van Aken S, Maris E, Mathieu C, Gillard P, Casteels K. One-year effectiveness and safety in young children aged 2-6 years with type 1 diabetes using an automated insulin delivery system: A real-world prospective cohort study. Diabetes Obes Metab. 2026 Jan;28(1):551-561. doi: 10.1111/dom.70228. Epub 2025 Oct 27.

    PubMed 41144887

  • De Meulemeester J, Valgaerts L, Massa G, Gies I, Depoorter S, Van Aken S, Chivu O, den Brinker M, Mouraux T, Van Loocke M, Lebrethon MC, Messaaoui A, Lysy P, Dooms L, Mathieu C, Casteels K, Gillard P. Real-World Glycemic and Person-Reported Outcomes After Tandem Control-IQ Initiation in Children With Type 1 Diabetes. J Clin Endocrinol Metab. 2025 Nov 18;110(12):3331-3341. doi: 10.1210/clinem/dgaf265.

    PubMed 40333328

  • De Meulemeester J, Keymeulen B, De Block C, Van Huffel L, Taes Y, Ballaux D, Spincemaille K, Lapauw B, Vanhaverbeke G, Lowyck I, Vercammen C, Colin IM, Preumont V, Charleer S, Fieuws S, Mathieu C, Gillard P. One-year real-world benefits of Tandem Control-IQ technology on glucose management and person-reported outcomes in adults with type 1 diabetes: a prospective observational cohort study. Diabetologia. 2025 May;68(5):948-960. doi: 10.1007/s00125-025-06366-x. Epub 2025 Feb 11.

    PubMed 39934368

  • Aernouts C, Belde SPW, Lambrechts J, Mertens J, Ledeganck KJ, Francque SM, De Block CEM. Metabolic dysfunction-associated steatotic liver disease is associated with worse time in ranges in type 1 diabetes. Diabetes Obes Metab. 2024 Sep;26(9):3781-3790. doi: 10.1111/dom.15723. Epub 2024 Jun 25.

    PubMed 38924290

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by Universitaire Ziekenhuizen KU Leuven at 38 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in range (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04414280, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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